RecruitingPhase 2NCT07103395

A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer

A Phase II Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) in Patients With Locally Advanced Non-Small Cell Lung Cancer


Sponsor

Sun Yat-sen University

Enrollment

56 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining chemotherapy before and during radiation therapy with two immunotherapy drugs can improve outcomes for people with Stage III non-small cell lung cancer that cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with Stage III non-small cell lung cancer that cannot be removed by surgery - Your cancer does not have EGFR, ALK, or ROS1 mutations - You have not received any prior treatment for this lung cancer - Your breathing and organ function are within acceptable levels **You may NOT be eligible if...** - You have already received chemotherapy, radiation, surgery, or immunotherapy for this cancer - You have certain lung function limitations - You are breastfeeding or unwilling to use contraception - Your organ function is too compromised Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant therapy

The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel/pemetrexed, cisplatin, Bevacizumab, iparomlimab and tuvonralimab, and thymosin alpha 1.

RADIATIONRadiotherapy

Definitive dose of hypofractionated radiotherapy was delivered to patients, with concurrent chemotherapy and surufatinib.

DRUGConsolidative therapy

Consolidation therapy consists of iparomlimab and tuvonralimab, surufatinib and thymosin alpha 1, for a total duration of 1 year.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07103395


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